The Gray Book on Global Medicines Development

by Dr Julian Gray MD PhD MBA

The text explains the process of developing a drug from laboratory to the market in a clear and comprehensive way, covering all aspects of the PharmaTrain syllabus. The Gray Book is a constantly updated e-text including hyperlinks to regulatory guidelines and other reference sources.

 

Content

  •  Outline of the Development Process
  • Discovery of New Medicines
  • Development OF Medicines: Planning
  • Non-Clinical Safety Testing
  • Pharmaceutical Development / Manufacturing
  • Regulatory Issues: Part 1
  • Introduction to Clinical Research
  • Statistics and Data Management
  • Drug Safety, Pharmacovigilance and Pharmacoepidemology
  • Introduction to Pharmacokinetics
  • Phase I Studies
  • Phase IIA Studies
  • Phase IIB and Phase III Studies
  • Regulatory Issues Part 2: Filing forApproval
  • Pharmacoeconomics
  • Patients
  • Project Valuation
  • Marketing, Information, Promotion and Education

 

SPECIAL OFFER For ECPM Students and Alumni

E-Book (personalised, not printable, password protected): new offer is following soon

Orders for print versions will be possible at the beginning of the new course cycle in September 2017.

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